This webinar is intended for formulators, process engineers, validation, regulatory compliance and quality assurance personnel, as well as production managers who want to ensure that their equipment and processes are in compliance with validation requirements of various regulatory bodies and directives.
Get trained on practical aspects of FDA process validation, equipment qualification, Data analysis, statistical tools for Process Quality Management, more. (see
full course description)
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Training Course
Syllabus:
How to Validate Equipment According to FDA Standards Webinar
This webinar course covers the following topics on validation of pharmaceutical product and process:
FDA Guidance on Process Validation: general principles and practices
Lifecycle and Process Validation
ICH Q10, FDA and EU - focus on validation
cGMP regulations and Process Validation Guidance
Data analysis and statistical tools for Process Quality Management (PQM)
Examples of statistical tools and ASTM standards
Process Verification vs. Process Validation
Why Should you Attend:
This webinar will provide an excellent insight into the practical aspects of the Process Validation and equipment qualification which will be an invaluable source of information related to regulatory activity.
Objectives of the Presentation:
This presentation aims at teaching participants about:
Qualification vs. validation vs. verification
Regulations for Process Validation: Review of FDA, GHTF, and GAMP requirements
Documentation and testing: Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ)
Acceptance criteria of equipment qualification Process Validation
Validation Protocol as per FDA standards
Seminar Summary:
Get trained on practical aspects of FDA process validation, equipment qualification, Data analysis, statistical tools for Process Quality Management, more. (see
full course description)